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This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes.
This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes.
Considering the rights and interests, the trial is divided into two phases. The first phase is a double-blind group, in which subjects are randomly assigned to the blank control group, the low-dose experimental group, and the high-dose experimental group to observe the changes in glycosylated hemoglobin and CGMS compared with the baseline, as well as safety events.
The second phase is an open-label group, in which the three groups are willing to freely enter the high-dose experimental group and further observe recovery and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose LC-Z300-01 | Experimental | Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 12-weeks of low-dose LC-Z300-01 randamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label. |
|
| high-dose LC-Z300-01 | Experimental | Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01. |
|
| Placebo | Placebo Comparator | Experimental: placebo + LC-Z300-01 Subjects will receive 12-weeks of placebo radamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo twice daily in blinding | Dietary Supplement | Administered placebo twice-daily for 12 weeks in blinding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | The differences in adverse events between the patients taking the drug and the placebo group were observed during the double-blind and open-label phases. | From baseline week 0 to week 26 |
| Change in glycated haemoglobin (HbA1c) | During the double-blind and open-label phases, the changes in dynamic blood glucose and CGMS values of patients taking the medication compared with the baseline were observed and compared with those in the placebo group. | From baseline week 0 to week 12 and to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time in Range (TIR) | During the double-blind and open-label phases, the changes in dynamic blood glucose and CGMS values of patients taking the medication compared with the baseline were observed and compared with those in the placebo group. | From baseline week 0 to week 12 and to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Chronic heart failure classified as being in New York Heart Association Class IV at screening,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-fen Xie, Prof. | Contact | +862181886824 | dr.lituo@smmu.edu.cn | |
| Tuo Li, Prof. | Contact | +86-13918507887 | zoe_leeto@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei-fen Xie, Prof. | Shanghai Changzheng Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 20003 | China |
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The total duration of the trial for individuals participating in this clinical trial is up to 30 weeks, including:
| Low-dose LC-Z300-01 twice daily in blinding | Drug | Administered twice-daily for 12 weeks in blinding |
|
|
| High-dose LC-Z300-01 twice daily in blinding | Drug | Administered twice-daily for 12 weeks in blinding |
|
|
| High-dose LCZ300-1 twice daily in open-label | Drug | Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label |
|
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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